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Expert Analytical Formulation Services
FromQuay Pharma
Quay Pharma has hugely experienced analytical specialists working alongside our formulation and manufacturing teams who provide expert advice and an enormous breadth of advanced analytical capabilities.
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Quay Pharma has hugely experienced analytical specialists working alongside our formulation and manufacturing teams who provide expert advice and an enormous breadth of advanced analytical capabilities. Their contribution is vital in our success in early-stage formulation development, stability studies, and clinical trial manufacture.
Analytical Services Include:
- Analytical method transfer, development and validation.
- Stability-indicating assays using UPLC and HPLC (including forced degradation studies).
- Formal and informal stability study design, storage and testing.
- Batch release and raw material testing.
- Chemical and physical testing.
- Chiral analysis.
- Dissolution testing and drug release profiling.
- Drug substance characterisation.
- The identification and quantification of impurities.
- Comparator studies.
- Testing of raw materials to ensure that each formulation component meets our quality requirements.
- In-process assays to establish that the manufacturing processes are meeting the standards set out in advance.
- Carrying out of final product assays to verify that product meets its specification.
- We employ stability testing to evaluate the useful shelf life of the product.